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Entering an Era of Clinical Trials

A CLINICAL TRIAL is a series of closely monitored and regulated experiments that evaluate the safety and effectiveness of a potential treatment before it can be put on the market and prescribed to patients. Clinical trials ensure that only safe and effective treatments are made available to the patients who need them. But getting a potential treatment through a clinical trial, and obtaining marketing approval from the FDA, can be a long and costly process.

Clinical Trial Facts

  • The Foundation recently launched its own clinical trial network, the National Eye Evaluation and Research network, to more quickly move promising treatments into human studies. Valproic acid is the first treatment being evaluated in the network.
  • Emerging treatments for diseases that affect fewer than 200,000 people may receive orphan status from the FDA. Orphan status can lead to a quicker FDA approval process and other marketing and clinical research benefits for the organization developing the treatment.
  • Similar to the FDA in the U.S., the European Medicines Agency (EMA) monitors and regulates clinical trials and treatments for organizations operating in the European Union.
"OVER THE LAST FEW YEARS THE FOUNDATION FIGHTING BLINDNESS has put the people, procedures, resources, and facilities in place to conduct rigorous human studies, which will ensure that treatments and cures are safe and effective for the people who need them. These efforts take several years and cost several million dollars, because of the intensive measurement, monitoring, and control that are required to accurately assess each therapy and gain FDA approval." - Gordon Gund